NCT06837194 Washed Microbiota Transplantation Combined With Enteral Nutrition for Gastroptosis
| NCT ID | NCT06837194 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Second Hospital of Nanjing Medical University |
| Condition | Gastroptosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 24 participants in total. It began in 2025-02-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a observational study to explore the efficacy and safety of washed microbiota transplantation (WMT) combined with nutritional support for gastroptosis patients
Eligibility Criteria
Inclusion Criteria: * Subjects must meet all of the following inclusion criteria to enter the study: 1. Clinically diagnosed with gastroptosis; 2. Meets the diagnostic criteria for malnutrition (fulfilling any one of the following two criteria): * Weight loss (weight loss \>5% within the last 6 months or \>10% over more than 6 months); * Low BMI (BMI \<18.5 kg/m² for individuals \<70 years old; BMI \<20 kg/m² for individuals ≥70 years old); 3. Males aged ≥18 years and non-pregnant, non-lactating females aged ≥18 years; 4. Willing to voluntarily sign a written informed consent form and agrees to follow medical advice for regular follow-up examinations and monitoring after the completion of treatment. Exclusion Criteria: * Subjects meeting any of the following exclusion criteria must be excluded from the study: 1. Patients with severe depression, anxiety, or cognitive impairment that affects normal physician-patient communication and treatment planning; 2. Patients with poor compliance who cannot accept treatment regimens such as nasogastric enteral nutrition; 3. Anticipated survival time \<3 months; 4. Clinically significant cardiovascular diseases, including heart failure (NYHA Class III-IV), uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, history of myocardial infarction, hemodynamic instability at enrollment, unstable vital signs, or anticipated risk events during treatment; 5. Poor pulmonary function deemed by investigators to impact study treatment (e.g., acute exacerbation of COPD or requirement for long-term oral/intravenous corticosteroids \[excluding inhaled corticosteroids\]); 6. Active severe clinical infections (\> Grade 2 per NCI-CTCAE v5.0), including patients with intestinal fungal, viral, or tuberculosis infections; 7. Inability to cooperate with intestinal tube placement or contraindications to intestinal tube placement; 8. Use of medications affecting or modulating gut microbiota within the past 48 hours; 9. Lack of legal capacity or restricted legal capacity; 10. Hematologic disorders unsuitable for blood draw examinations; 11. Other severe medical conditions deemed by investigators to preclude patient enrollment.
Contact & Investigator
Faming Zhang
PRINCIPAL INVESTIGATOR
The Second Hospital of Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06837194 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Gastroptosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06837194 currently recruiting?
Yes, NCT06837194 is actively recruiting participants. Contact the research team at fzhang@njmu.edu.cn for enrollment information.
Where is the NCT06837194 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06837194 clinical trial?
NCT06837194 is sponsored by The Second Hospital of Nanjing Medical University. The principal investigator is Faming Zhang at The Second Hospital of Nanjing Medical University. The trial plans to enroll 24 participants.